Cleared Traditional

K033718 - MAXBRAID POLYESTER PLUS AND POLYETHYLEN...

K033718 is the FDA 510(k) clearance for MAXBRAID POLYESTER PLUS AND POLYETHYLEN... by Arthrotek, Inc.. It is a Class 2 General & Plastic Surgery device (product code GAT) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K033718 · Arthrotek, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
78d
Days
Class 2
Risk

K033718 is an FDA 510(k) clearance for the MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Arthrotek, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 12, 2004 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arthrotek, Inc. devices

Submission Details

510(k) Number K033718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2003
Decision Date February 12, 2004
Days to Decision 78 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 95
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K033718.
SMITH & NEPHEW ULTRABRAID SUTURE
K041216 · Smith & Nephew, Inc. · Jun 2004
DURABRAID SUTURE
K040789 · Smith & Nephew, Inc. · Jun 2004
FORCE FIBER BLUE CO-BRAIDED POLYETHYLENE NONABSORBABLE SURGICAL SUTURE
K040472 · Teleflex Medical · Mar 2004
FORCE FIBER
K033654 · Teleflex Medical · Jan 2004
ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239
K032245 · Arthrex, Inc. · Jan 2004
STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM
K032901 · Stryker Endoscopy · Dec 2003